FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemoglobin Control Solution
DI: 06935740733854
·
Model: HQ-A,1mL/bottle×3/box
·
Urit Medical Electronic Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Hemoglobin Control Solution
- Primary DI
- 06935740733854
- Version / Model
- HQ-A,1mL/bottle×3/box
- Company Name
- Urit Medical Electronic Co., Ltd.
- Labeler DUNS
- 653742429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-07-12
- Public Version
- 1
- Public Version Date
- 2024-07-22
- Public Version Status
- New
- Public Device Record Key
- bd3acfdb-39b4-4439-9e9f-a5e6d0ba70b7
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GGM | Control, Hemoglobin | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57272 | Haemoglobin detection IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of haemoglobin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935740733854 | GS1 | ||||
| Unit of Use | 86935740733850 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius